Semaglutide for Opioid Use Disorder
(SHORE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Brigham and Women's Hospital

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.

Eligibility Criteria

This trial is for individuals starting treatment with buprenorphine for opioid use disorder. Participants will be randomly assigned to receive either semaglutide or a placebo in weekly injections over 12 weeks.

Inclusion Criteria

I am 18 or older and speak English.

DSM-5 diagnosis of opioid use disorder, severe

I started taking buprenorphine under the tongue within the last 60 days.

+3 more

Exclusion Criteria

Psychotic disorder, active suicidality or homicidality or any psychiatric condition that impairs ability to provide informed consent

BMI < 25mg/kg2

I have been diagnosed with diabetes.

+8 more

Participant Groups

The study tests if semaglutide affects cravings and reactions to drug cues in people with opioid addiction. It's also looking at how safe and tolerable the drug is as a potential treatment option.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

This arm will receive semaglutide (n=23). All participants will initially receive 0.25mg for 4 weeks, and then as tolerated dose will be increased to 0.5mg for 4 weeks. Then as tolerated, the dose will be increased to 1.0mg for 4 weeks.

Group II: PlaceboPlacebo Group1 Intervention

This arm will receive saline placebo (n=23).

Semaglutide is already approved in European Union, United States, Canada, Japan, United States, United States for the following indications:

🇪🇺 Approved in European Union as Ozempic for: